Routine Intraoperative Transesophageal Echocardiography (TEE) on Surgical Management in Paediatric Cardiac Surgery: Impact and Cost-effective analysis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- DGAFMS
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- To estimate the proportion of alterations in surgical management (including the need for repeat bypass run) due to TEE findings.
研究概览
简要总结
Transesophageal echocardiography (TEE) preoperative in paediatric cardiac surgery has many applications. Over the past few decades, perioperative echocardiography has solidified its role as a critical diagnostic and perioperative management tool for patients with congenital heart disease (CHD). Perioperative TEE has proved to be invaluable in confirming the preoperative diagnosis, formulating the surgical plan, evaluating immediate operative results, identifying patients with residual defects, and guiding surgical revisions. Residual lesion or defect after cardiac surgery is known and this not only hampers the fast-tracking of the patient but also utilises huge resources of the institute while the patient stays on a ventilator and in ICU.
After standard non-invasive monitoring, anaesthesia will be induced. TEE probe will be inserted after induction of the child and standard images will be recorded. Examinations will be performed using GE Vivid T8 echocardiography platform. Relevant images will be stored for future review and comparison. Heart rate (HR), systolic, diastolic, mean arterial blood pressure (MAP), and oxygen saturation will be invasively monitored throughout the surgery. All surgical procedures will be performed by experienced surgeons using standardized techniques. Cardiopulmonary bypass (CPB) and anaesthesia management will be performed according to our standard operating procedures. Any change or modification in the surgical management will be noted before the start of the surgery and after coming off bypass to look for adequacy of surgical correction, cardiac function, and any significant residual lesion and the findings will be conveyed to the operating surgeon. Any significant residual lesion, requiring surgical revision or a second CPB will be noted as an impact of TEE on surgical decision-making. TEE examination will also be repeated after the second CPB. The patients will be observed and evaluated for residual lesions and complications during the ICU stay. Apart from the demographic profile of the patient collected operative data will include aortic cross-clamping (CCT), and cardiopulmonary bypass (CPB). Any adverse events will be recorded. ICU measurements, postop ICU stay, Duration of MV, and any TEE-related adverse event. The cost benefit analysis will be done from health care providers prespective and incremental cost effectiveness ratio would be calculated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Paediatric patients (less than 18 yrs) with congenital heart disease (cyanotic or acyanotic) undergoing on-pump cardiac surgery for correction of defect at the Army Institute of Cardiothoracic Sciences, AFMC for various indications.
排除标准
- •Patients in whom TEE is not inserted due to various reasons (history of dysphagia or prior esophageal surgery, unrepaired tracheoesophageal fistula, esophageal diseases, like stricture, diverticulum or varices, severe coagulopathy, and seropositivity for hepatitis viruses or human immunodeficiency virus and patient on the antiplatelet agent, low molecular weight heparin or heparin infusion) will be excluded from the study.
结局指标
主要结局
To estimate the proportion of alterations in surgical management (including the need for repeat bypass run) due to TEE findings.
时间窗: Perioperative period (immediate before surgery and immediately after surgery)
次要结局
- Cost effective analysis of the change in surgical and postop medical management due to new findings, residual lesions, and rerun of bypass.(Perioperative period (immediate before surgery and immediately after surgery))
